Steerable medical device

ABSTRACT

A steerable medical device is used to controllably introduce a guidewire or other medical instrument into a body of a patient and direct placement of the guidewire or other medical instrument in the body of the patient. The steerable medical device can include an elongated member, a steering mechanism, and an attachment member. The elongated member extends along a longitudinal axis and comprises a deflectable distal portion that is deflectable off of the longitudinal axis. The steering mechanism is adapted to control longitudinal and rotational movement of the elongated member and to control off-axis deflection of its deflectable portion. The attachment member is removably couplable to another medical device. The attachment member is moveably coupled to the steering mechanism and the elongated member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of Provisional U.S.Patent Application Ser. No. 61/076,399, filed Jun. 27, 2008, theentirety of which is incorporated herein by reference.

TECHNICAL FIELD

The invention generally relates to a steerable medical device, and moreparticularly to a device for receiving and directing another medicalinstrument, such as a guidewire, to a target position in a body of apatient.

BACKGROUND INFORMATION

In some medical procedures, such as those to treat conditions in theupper urinary tract of a patient, medical instruments must be insertedinto the body of the patient and positioned at a target site within thepatient's body. In some procedures, an endoscope, such as a cystoscope,is first introduced into the bladder of the patient. A guidewire oranother medical instrument then is introduced into the patient's bodythrough the cystoscope. The guidewire is passed through a workingchannel of the cystoscope until the distal or insertion end of theguidewire exits the distal end of the cystoscope and enters the bladderof the patient. The advancing distal end of the guidewire must thensomehow be directed to the target location, such as to and through theentrance of the patient's ureter. Directing the guidewire into thepatient's ureter with known techniques and tools often proves difficult.

SUMMARY OF THE INVENTION

It is an object of the invention to controllably direct a guidewire orother medical instrument to a target position within a body of a patientsuch as a ureter of the patient. A steerable medical device according tothe invention can be used to help better direct an advancing guidewireor other advancing instrument such as a stone retrieval basket, biopsytool, laser fiber, or small catheter, for example. The device can beused with an endoscope (whether rigid, semi-rigid, or flexible) or withsome other tool, particularly by passing the device through a workingchannel of the endoscope or other tool. Whether or not used through theworking channel of an endoscope or other tool, the steerable medicaldevice achieves easily and inexpensively the desired enhanced distaldirectability of an instrument that is advanced through the device. Whencoupled to and passed through the working channel of an endoscope orother tool, a steerable medical device according to the invention canreceive a guidewire or other instrument and allow, with one-handedproximal operation, the distal manipulation required to controllablydirect the distal end of the guidewire or other instrument to thedesired target location within a patient's body. The steerable medicaldevice then can be decoupled from the endoscope or other tool andremoved from its working channel to leave the guidewire or otherinstrument at that location within the patient.

In one aspect, the invention relates to a steerable medical devicecomprising an elongated member, a steering mechanism, and an attachmentmember. The elongated member extends along a longitudinal axis. Theelongated member includes a proximal end and a distal end and defines alumen extending from the proximal end to the distal end. The elongatedmember includes a deflectable portion that includes the distal end andthat is movable off of the longitudinal axis. The steering mechanism isadapted to control movement of the deflectable portion of the elongatedmember. At least a portion of the steering mechanism is fixedly coupledto at least a portion of the elongated member such that rotation of thesteering mechanism in one direction about the longitudinal axiscorrespondingly rotates the elongated member in that one direction aboutthe longitudinal axis. The attachment member is removably couplable toanother medical device, and the elongated member and steering mechanismare movably coupled to the attachment member.

Embodiments according to this aspect of the invention can includevarious features. For example, the lumen of the elongated member can beaccessible through an opening defined by the steering mechanism. Thelumen defined by the elongated member can be a working lumen, and can beadapted to receive at least one of a guidewire, a stone retrievalbasket, a biopsy tool, a laser fiber, or a catheter. The elongatedmember can further define a second lumen extending from the proximal endof the elongated member to the distal end of the elongated member.

The steerable medical device can also include a pull-wire coupled to theelongated member. The pull-wire can be adapted to be moved by thesteering mechanism and to move the deflectable portion of the elongatedmember off of the longitudinal axis. The pull-wire can be disposed inthe second lumen of the elongated member.

In another example, at least a portion of the deflectable portion of theelongated member can be adapted to reduce deflection resistance duringmovement of the deflectable portion. For example, at least a portion ofthe deflectable portion of the elongated member can define at least oneof a recess, slot, notch, or opening adapted to reduce resistance of theelongated member during movement of the deflectable portion of theelongated member.

In another example, the proximal end of the elongated member can befixedly coupled to a proximal end of the steering mechanism. In someembodiments, the steering mechanism also includes an actuator adapted tocontrol movement of the deflectable portion of the elongated member. Theactuator is movable between a first position and a second position andcan be adapted to move the deflectable portion of the elongated memberoff of the longitudinal axis as the actuator is moved from its firstposition towards its second position. The steerable medical device caninclude a pull-wire extending from the steering mechanism to the distalend of the elongated member, and at least a portion of the pull-wire canbe coupled to the actuator. The actuator can be disposed over a housingportion of the steering mechanism and can be movable with respect to thehousing portion.

In some embodiments, the steering mechanism also includes a fastener.The fastener can have a locked position and an unlocked position. Thesteering mechanism and the elongated member are independently movable ofthe attachment member when the fastener is in its unlocked position. Theattachment member can be adapted to remain substantially stationary withrespect to the other medical device when the attachment member iscoupled to the other medical device and the steering mechanism andelongated member are rotated in the one direction about the longitudinalaxis. The attachment member can be adapted to couple the steerablemedical device to a port of an endoscope.

In another example, the steerable medical device includes an indiciaindicating the position of the distal end of the elongated memberrelative to a distal end portion of the other medical device.

In some embodiments, the steerable medical device also includes areinforcement shaft including a proximal end and a distal end. Thereinforcement shaft can be adapted to reinforce and be disposed over atleast a portion of the elongated member. A portion of the reinforcementshaft can be disposable within the steering mechanism. The proximal endof the reinforcement shaft can be fixedly coupled to the steeringmechanism and to the elongated member. The distal end of thereinforcement shaft can adapted to be inserted into a port of the othermedical device.

In another aspect, the invention generally involves a steerable medicaldevice that includes an elongated member, a housing, an actuator, and anattachment member. The elongated member extends along a longitudinalaxis. The elongated member includes a proximal end and a distal end anddefines a lumen extending from the proximal end of the elongated memberto the distal end of the elongated member. The elongated member isadapted to be moved to a deflected position in which a deflectableportion of the elongated member is moved off of the longitudinal axis.The housing includes a proximal end and a distal end. The housing isfixedly coupled to the elongated member such that when the housing ismoved in one rotational direction about the longitudinal axis theelongated member correspondingly rotates in the one rotational directionabout the longitudinal axis. The actuator is movably coupled to thehousing and is adapted to control movement of the deflectable portion ofthe elongated member. The attachment member is removably couplable toanother medical device. The attachment member defines a proximal end anda distal end and is disposable over at least a portion of the elongatedmember. At least a portion of the attachment member is slidablyreceivable by the housing. The housing and the elongated member areindependently movable of the attachment member when a position fastenerdisposed on the housing is unlocked.

In yet another aspect, the invention generally involves a steerablemedical device that includes an elongated member, an attachment member,a reinforcement shaft, and a steering mechanism. The elongated memberextends along a longitudinal axis and includes a proximal end and adistal end. The elongated member defines a lumen extending from theproximal end to the distal end. The elongated member includes adeflectable portion that includes the distal end and that is movable offof the longitudinal axis. The elongated member is adapted to be at leastpartially disposed in a working channel of another medical device. Theattachment member is adapted to removably couple the steerable medicaldevice to the other medical device. The attachment member defines aproximal end and a distal end, and the distal end of the attachmentmember is adapted to be removably coupled to a port of the other medicaldevice. The reinforcement shaft is adapted to reinforce at least aportion of the elongated member and is disposable over at least aportion of the elongated member. The reinforcement shaft defines aproximal end and a distal end, and the distal end of the reinforcementshaft is adapted to be inserted into the port of the other medicaldevice. The steering mechanism is adapted to control movement of theelongated member. The steering mechanism includes a housing portionfixedly coupled to at least a portion of the elongated member such thatrotation of the steering mechanism in one direction about thelongitudinal axis correspondingly rotates the elongated member in thatone direction about the longitudinal axis. The steering mechanisminclude an actuator adapted to control movement of the deflectableportion off of the longitudinal axis.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention willbecome better understood by reference to the following detaileddescription when considered in conjunction with the accompanyingdrawings. The drawings are for illustrative purposes only and are notnecessarily to scale. Generally, emphasis is placed on conveying certainconcepts and aspects according to the invention, therefore the actualdimensions of embodiments of the present invention, and theirproportions to other medical instruments, may vary from the drawings.

FIG. 1 is a schematic illustration of a steerable medical deviceaccording to an embodiment of the invention.

FIG. 2 is a cross-section of the steerable medical device of FIG. 1taken along line A-A.

FIGS. 3 and 4 are side views of a steerable medical device according toan embodiment of the invention in a first position and a secondposition, respectively.

FIG. 5 is a top view of a portion of the steerable medical device ofFIG. 3.

FIG. 6 is a cross-section of the portion of the steerable medical deviceof FIG. 5 taken along line C-C.

FIG. 7 is a cross-section of a portion of the steerable medical deviceof FIG. 3 taken along line B-B.

FIG. 8 is an end view of the steerable medical device of FIG. 3.

FIG. 9 is an embodiment of a portion of a steerable medical deviceaccording to an embodiment of the invention.

FIG. 10 is an embodiment of a portion of a steerable medical deviceaccording to an embodiment of the invention.

FIGS. 11-13 are side views of the steerable medical device of FIG. 3attached to an endoscope in a first, second, and third configuration,respectively.

FIG. 14 is a side view of the endoscope of FIGS. 11-13 with thesteerable medical device removed.

DESCRIPTION

Apparatuses for directing the introduction and insertion of anothermedical instrument (such as a guidewire, stone retrieval basket, biopsytool, laser fiber, small catheter, etc.) to a target location in a bodyof a patient are described herein, as are related methods. Theseapparatuses can be used through the working channel of an endoscope(whether rigid, semi-rigid, or flexible) or other tool. In someembodiments according to the invention, a steerable medical device isconfigured to be removably coupled to a rigid endoscope, some other typeof endoscope (e.g., semi-rigid or flexible), or some other type of toolhaving a working channel and typically having some imaging capability asan endoscope usually does. A portion of the steerable medical device canbe inserted into the body of the patient via the endoscope or else itcan be inserted directly into the patient's body, and in any event thesteerable medical device can be used to controllably introduce anddirect a guidewire, or other medical instrument, into the body of thepatient. The steerable medical device is adapted to direct the advancingend of the guidewire or other instrument to a target location in thebody of the patient. The steerable medical device can then be uncoupledfrom the endoscope or other tool and removed from the patient's bodywhile leaving the guidewire or other medical instrument in the body ofthe patient.

In one embodiment, as schematically illustrated in FIGS. 1 and 2, asteerable medical device (also referred to herein as “device”) 100includes an elongated member 110, a steering mechanism 130, and anattachment member 160. At least a portion of the device 100 can beadapted to be received by (or inserted into) a working channel of anendoscope (whether rigid, semi-rigid, or flexible) or other such tool ormedical device. For example, at least a portion of the elongated member110 can be adapted to be received by the working channel of a rigidendoscope such as a cystoscope or a laparoscope. Although the steerablemedical device 100 is capable of being used on its own without passingthrough the working channel of some type of endoscope or other tool, itcan be particularly useful when used through the working channel of anendoscope or other tool and perhaps most useful when used through theworking channel of a rigid or semi-rigid endoscope.

The elongated member 110 can be tubular and includes a proximal end 113and a distal end 115 and defines a lumen 112 extending from the proximalend to the distal end. The elongated member 110 includes a deflectableportion 114. The entirety of the elongated member 110 extends along alongitudinal axis L when the deflectable portion 114 is straight orsubstantially straight. The deflectable portion 114 can be deflected offof the axis L. The deflectable portion 114 includes the distal end 115of the elongated member 110.

The steering mechanism 130 is adapted to control deflection of thedeflectable portion 114 of the elongated member 110. The steeringmechanism 130 is disposed at or over the proximal end 113 of theelongated member 110. The steering mechanism 130 includes a proximal end133 and a distal end 135. The steering mechanism 130 also defines anopening or lumen 132. In some embodiments, as illustrated in FIG. 2, thelumen 132 of the steering mechanism 130 receives at least a portion ofthe elongated member 110 including the proximal end 113.

In some embodiments, the steering mechanism 130 is coupled to theelongated member 110. For example, as illustrated in FIG. 2, theproximal end 133 of the steering mechanism 130 is fixedly coupled (by,for example, an adhesive, an interference fit, or in some other manner)to the proximal end 113 of the elongated member 110. Because thesteering mechanism 130 and the elongated member 110 are fixedly coupled,rotation of the steering mechanism in one direction (such as clockwiseabout the axis L) correspondingly rotates the elongated member in thesame direction. Furthermore, because the steering mechanism 130 andelongated member 110 are fixedly coupled, movement of the steeringmechanism 130 in a longitudinal direction (meaning in a distal orproximal direction, such as along the axis L) correspondingly moves theelongated member 110 in the same longitudinal direction.

The elongated member 110 is also referred to herein as the tubularmember 110, although the shape of the elongated member 110 does not haveto be cylindrical. It can have any of a variety of cross-sectionalshapes instead of circular, but a circular or substantially circularcross-sectional shape for the elongated member 110 is acceptable.

The attachment member 160 is adapted to removably couple the steerablemedical device 100 to an endoscope (whether rigid, semi-rigid, orflexible, but in preferred embodiments the attachment member 160removably couples the device 100 to a rigid or semi-rigid endoscope) orother such instrument or tool with a working channel and typically someimaging capability as endoscopes usually have (not shown in FIGS. 1 and2). For example, in some embodiments, a distal end 165 of the attachmentmember 160 is adapted to receive, be disposed over, or otherwise becouplable to a portion of the endoscope. In the illustrated embodiment,the distal end 165 of the attachment member 160 defines a recess 167configured to be coupled to a portion of the endoscope. The attachmentmember 160 is shown disposed over a portion of the elongated member 110that is distal to the steering mechanism 130.

The attachment member 160 is adapted to guide longitudinal movement ofthe steering mechanism 130 (along the axis L for example). At least aportion of the attachment member 160 is disposable within the lumen 132of the steering mechanism 130. For example, as illustrated in FIG. 2, aguide portion 168 of the attachment member 160 is disposable within atleast some of the lumen 132 of the steering mechanism 130. The steeringmechanism 130 is movable with respect to the attachment member 160. Forexample, the steering mechanism 130 can be slidable and/or rotatablewith respect to the guide portion 168 of the attachment member 160.

Referring to FIGS. 3-8 and 11-13, another embodiment of a steerablemedical device 200 according to the invention is illustrated. Thesteerable medical device 200 is adapted to be attached to anothermedical device or tool, such as a rigid endoscope S, and is adapted toallow for controlled articulation of a portion of the device 200 so thatanother medical instrument, such as a guidewire G, can be controllablydirected to a target location in a body of a patient.

Referring to FIG. 3, the device 200 includes an elongated or tubularmember 210, a steering mechanism 230, and an attachment member 260. Thetubular member 210 is adapted to be inserted through a working channelof the endoscope. The steering mechanism 230 is adapted to deflect adistal portion of the tubular member 210 towards the target location inthe body of the patient so that the advancing distal end of theguidewire (or other instrument) can be controllably directed or guidedto the target location. The attachment member 260 is adapted to couplethe device 200 to the endoscope.

The tubular member 210 can be inserted into the working channel of theendoscope S through a port P of the endoscope, as illustrated in FIG.11. The tubular member 210 is adapted to receive another medicalinstrument, such as a guidewire, stone retrieval basket, biopsy tool,laser fiber, or small catheter, for example. The guidewire, for example,can be inserted into the lumen 212 at the proximal end 213 of thetubular member 210. The guidewire can be passed through the lumen 212 ofthe tubular member 210 until a advancing (or leading) end of theguidewire extends beyond the distal end 215 of the tubular member 210.

The tubular member 210 is also adapted to be controllably articulatedsuch that the tubular member can be used to direct the guidewire (orother instrument) to a target location in the body of the patient. Atleast a portion of the tubular member 210 is adapted to be deflectable,or steerable. The tubular member 210 includes a proximal end 213 and adistal end 215, and defines a lumen 212 extending between the proximalend and the distal end. The lumen 212 of the elongated member 210 canreceive the guidewire (or other instrument).

The elongated member 210 includes a deflectable portion 214 that isadapted to be deflected in at least a first direction. In someembodiments, the deflectable portion 214 includes the distal end 215 ofthe elongated member. The deflectable portion 214 of the tubular member210 allows an operator to target a specific location within the body ofthe patient. For example, the tubular member 210 of the device 200 canbe inserted into a bladder of the patient through the working channel ofthe endoscope already positioned in the patient's bladder. The operatorcan then deflect the tubular member such that it approximates theentrance to the patient's ureter, or other place of treatment within thepatient's bladder.

The entirety of the tubular member 210 extends along a longitudinal axisL when the deflectable portion 214 is straight or substantiallystraight, as illustrated in FIG. 3. The deflectable portion 214 of thetubular member 210 can be deflected in a first direction off of (or awayfrom) the longitudinal axis L, as illustrated in FIG. 4.

In some embodiments, the tubular member of a steerable medical device isadapted to reduce deflection resistance in the tubular member. Forexample, as illustrated in FIG. 9, at least a portion of a tubularmember 310, such as a deflectable portion 314, defines at least one of arecess, slot, notch, or opening. The recess, slot, notch, or opening isadapted to help reduce resistance of the tubular member 310 duringdeflection of the distal end 315 of the tubular member. In theillustrated embodiment, for example, the deflectable portion 314 of thetubular member 310 defines a series of notches 324 (or recesses, slots,or openings). In some embodiments, each notch of the series of notches324 extends along an axis different than the longitudinal axis L definedby the tubular member 310. In the embodiment illustrated in FIG. 9, thenotches 324 extend along an axis T that is transverse to thelongitudinal axis L. In other embodiments, the deflectable portion ofthe tubular member is constructed of a material adapted to reduceresistance to deflection, such as a material that is thinner or moreflexible that the material of which the remaining portion of the tubularmember is constructed.

In some embodiments, as illustrated in FIGS. 7 and 8, the device 200includes a pull-wire 216. The pull-wire 216 is adapted to be moved bythe steering mechanism 230 to move the deflectable portion 214 of thetubular member 210 off of the longitudinal axis L.

In some embodiments, the lumen 212 defined by the tubular member 210 isa first (or working) lumen and the tubular member 210 further defines asecond lumen 222, as illustrated in FIGS. 7 and 8. The second lumen 222extends from the proximal end 213 of the tubular member 210 to thedistal end 215 of the tubular member. The first and second lumens 212,222 can have varying cross-sectional shapes and/or diameters. Forexample, the working lumen 212 can be larger than the second 222 lumen.In another example, the working lumen can have a circularcross-sectional shape and the second lumen can have a differentcross-sectional shape, such as hexagonal, oval, or square.

The pull-wire 216 can be disposed within the second lumen 222. Thepull-wire 216 defines a proximal end 217 and a distal end (not shown inFIGS. 3-8). The proximal end 217 of the pull-wire 216 is coupled to thesteering mechanism 230, as illustrated in FIG. 8. The distal end of thepull-wire 216 is coupled to the distal end 215 of the tubular member210. In some embodiments, as illustrated in FIG. 9, an attachment ring328 is disposed on the distal end 315 of the tubular member 310. Thedistal end 319 of the pull-wire 316 is coupled to the attachment ring328.

The tubular member can be constructed of any suitable material. Forexample, the tubular member can be constructed of a biocompatiblepolymeric material or a thermoplastic elastomer. In another example, thetubular member defining the first and second lumens can be constructedfrom a Pebax® extrusion.

The tubular member can be constructed of a flexible, semi-rigid, orrigid material. If the tubular member is constructed of a more rigidmaterial, such as Teflon® or nylon, it is beneficial for the deflectableportion of the tubular member to be adapted to decrease deflectionresistance, such as by having a series of notches as described above.

Referring to FIGS. 3-8, the steering mechanism 230 of the device 200 isadapted to control movement of the deflectable portion 214 of thetubular member 210. The steering mechanism 230 is adapted to becontrolled by a single hand of an operator. For example, a physician cancontrol movement of the steering mechanism 230 with one hand while usingthe other hand to control a guidewire being inserted into the body ofthe patient through the tubular member 210.

The steering mechanism 230 includes a proximal end 233 and a distal end235. In some embodiments, the steering mechanism 230 is disposed at orover the proximal end 213 of the tubular member 210. At least a portionof the steering mechanism 230 is fixedly coupled to at least a portionof the tubular member 210. For example, the proximal end 233 of thesteering mechanism 230 can be fixedly coupled to the proximal end 213 ofthe tubular member 210. The steering mechanism 230 and tubular member210 are fixedly coupled such that rotation of the steering mechanism inone direction about the longitudinal axis L correspondingly rotates theelongated member in that one direction about the longitudinal axis.Similarly, movement of the steering mechanism in one longitudinaldirection (such as in a proximal or distal direction along thelongitudinal axis L) correspondingly moves the elongated member in thatone longitudinal direction.

In some embodiments, at least a portion of the steering mechanism 230defines an opening or lumen 232, as illustrated in FIG. 8. The lumen 232of the steering mechanism 230 is adapted to receive at least a portionof the tubular member 210. In the illustrated embodiment, the lumen 232of the steering mechanism 230 receives (or is disposed over) theproximal end 213 of the tubular member 210.

In some embodiments, the steering mechanism 230 includes an actuator 244and a housing 240 (also referred to herein as “housing portion”). In theillustrated embodiment, the actuator 244 is disposed over a portion ofthe housing 240 of the steering mechanism 230. The actuator 244 ismovable with respect to the housing 240, as described in more detailherein.

The actuator 244 is adapted to control movement of the deflectableportion 214 of the tubular member 210 off of the longitudinal axis L.For example, the actuator 244 can be used to direct or controldeflection of the deflectable portion 214 of the tubular member 210.

As illustrated in FIGS. 3 and 4, the actuator 244 is movable, withrespect to the housing 240, between a first position (FIG. 3) and asecond position (FIG. 4). When the actuator 244 is in its firstposition, the tubular member 210 extends along the longitudinal axis L(or is straight). The actuator 244 is adapted to move the deflectableportion 214 of the tubular member 210 away from the longitudinal axis Las the actuator is moved from its first position towards its secondposition. In some embodiments, the actuator 244 is moved to its secondposition by sliding the actuator in the direction of arrow D, asillustrated in FIG. 4. When the actuator 244 is in its second position,the deflectable portion 214 of the tubular member 210 is off of thelongitudinal axis L.

In some embodiments, the steering mechanism is adapted to limit movementof the actuator. For example, in the illustrated embodiment, aprotrusion 246 on the housing 240 is adapted to limit the slidingmovement of the actuator 244.

As illustrated in FIG. 10, in some embodiments, an actuator 344 of asteering mechanism 330 includes a portion 349 adapted to be more easilygripped, grasped, or pulled by an operator. For example, the actuator344 can include a contoured portion 349 adapted to be gripped by anoperator. In other embodiments, the portion can have a differentconfiguration adapted to allow the user to more easily control actuationof the actuator.

Although the actuator 244 is illustrated as being a slidable actuatordisposed over a portion of the housing 240 of the steering mechanism230, in other embodiments, the actuator has a different configuration.For example, the actuator can be a slide, button, lever, or another typeof actuator disposed on the steering mechanism.

In some embodiments, at least a portion of the pull-wire 216 is coupledto the actuator 244. For example, as illustrated in FIG. 8, the proximalend 217 of the pull-wire 216 is coupled to the actuator 244 of thesteering mechanism 230. In the illustrated embodiment, the pull-wire 216extends through an opening 247 (illustrated in FIGS. 5 and 6) defined bya portion of the actuator 244. As the actuator 244 is moved towards itssecond position, the actuator moves (or pulls on) the pull-wire 216causing the pull-wire to deflect the deflectable portion 214 of thetubular member 210.

Although the device 200 is illustrated and described as including asingle pull-wire 216 and as including a tubular member 210 movable inone direction off of the longitudinal axis L, in other embodiments, thedevice can include more than one pull-wire and the tubular member can bemovable in more than one direction off of the longitudinal axis L. Forexample, in one embodiment, the device includes a tubular member thatincludes a deflectable portion that is moveable in one direction, suchas to the right from the perspective of the operator, and anotherdirection different than the one direction, such as to the left from theperspective of the operator. In another embodiment, the deflectableportion of the tubular member is moveable (or deflectable) 360 degreesabout the longitudinal axis L. In some embodiments, the device includestwo, three, four, or more pull-wires adapted to move the tubular memberoff of the longitudinal axis L. In some embodiments, the tubular memberdefines more than two lumens. For example, the tubular member can definefour lumens, such as to accommodate four pull-wires.

The housing 240 of the steering mechanism 230 includes a proximal end243 and a distal end 245. In some embodiments, the housing 240 definesthe opening or lumen 232 of the steering mechanism 230. For example, insome embodiments, the lumen 232 extends from a proximal opening 234 atthe proximal end 243 of the housing 240 to a distal opening 236 at thedistal end 245 of the housing.

The proximal end 213 of the tubular member 210 is disposed in (orreceived in) the lumen 232 of the housing 240. The lumen 212 of thetubular member 210 is accessible through the proximal opening 243 of thehousing 240. For example, a guidewire, stone retrieval basket, biopsytool, laser fiber, small catheter, or another medical instrument can beinserted into the lumen 212 of the tubular member 210 through theproximal opening 243 of the housing 240.

In some embodiments, the housing 240 is the portion of the steeringmechanism 230 fixedly coupled to the tubular member 210. For example,the proximal end 243 of the housing 240 can be fixedly coupled to theproximal end 213 of the tubular member 210. Because the housing 240 andtubular member 210 are fixedly coupled, when the housing of the steeringmechanism 230 is rotated in one direction about the longitudinal axis L,the tubular member correspondingly moves or rotates in that onedirection about the longitudinal axis L. Similarly, when the housing 240of the steering mechanism 230 is moved in one longitudinal direction,for example in a distal direction along the longitudinal axis L, thetubular member correspondingly moves in that one longitudinal direction.

In some embodiments, the steering mechanism 230 of the device 200further includes a fastener 250 (also referred to herein as a “positionfastener”). The fastener 250 is adapted to fix the position of thesteering mechanism 230, and thus the tubular member 210, with respect tothe attachment member 260. The fastener 250 has an unlocked position anda locked position. When the fastener 250 is in the unlocked position,the steering mechanism 230 and tubular member 210 are independentlymovable of the attachment member 260. When the fastener 250 is in itslocked position, as illustrated in FIG. 6, the steering mechanism 230and tubular member 210 are fixed with respect to (or are notindependently movable of) the attachment member 260.

The fastener 250 is biased towards its locked position, such as viasprings 254. When the fastener 250 is locked, a portion 252 of thefastener engages a portion of the attachment member 260. In theembodiment illustrated in FIG. 6, a portion 252 of the fastener 250 isengaged with or overlays one of a series of teeth 284. To move thetubular member 210 with respect to the attachment member 260, thefastener 250 is pushed downwards towards the housing 240 and the portion252 of the fastener disengages the tooth.

The fastener 250 allows an operator to selectively longitudinallyposition the tubular member 210, such as to achieve a certain depth inthe body of the patient or extension of the tubular member 210 beyond adistal end of the endoscope or to accommodate variations in lengths ofvarious endoscopes or distal optics equipment, and then fasten or fixthe tubular member with respect to the attachment member 260 to preventfurther longitudinal movement.

The attachment member 260 of the steerable medical device 200 is adaptedto removably couple the device to the endoscope. For example, theattachment member 260 is adapted to removably couple the device 200 tothe port of the endoscope. By being removable, the steerable medicaldevice 200 can be coupled to (or attached to) the endoscope and then beremoved from the endoscope at the operator's discretion.

When the attachment member 260 is coupled to the endoscope, theattachment member remains substantially stationary with respect to theendoscope when the steering mechanism 230 and the tubular member 210 aremoved in at least one of a rotational direction about the longitudinalaxis L or a longitudinal direction along the longitudinal axis.

In some embodiments, the distal end 265 of the attachment member 260 isadapted removably couple to the endoscope. For example, as illustratedin FIG. 6, the distal end 265 of the attachment member 260 defines arecessed portion 267 adapted to be coupled to or disposed over a portionof the endoscope. In some embodiments, the distal end 265 of theattachment member 260 is adapted to snap onto the port of the endoscope.In other embodiments, the attachment member 260 is coupled to theendoscope using another known coupling means, including an adhesive, aninterference fit, or interlocking recesses, among others.

Once the attachment member 260 of the device 200 is coupled to theendoscope, the operator need not continue to manually support the devicebecause the coupling of the attachment member to the endoscope willsupport the device. Thus, the operator is able to use one hand tocontrol the actuator 244 of the steering mechanism 230 and the otherhand to manipulate the guidewire, or other medical instrument, beinginserted into the working channel of the endoscope and into the body ofthe patient.

The steering mechanism 230 and the tubular member 210 are movablycoupled to the attachment member 260. As illustrated in FIGS. 3 and 4,the attachment member 260 can be disposed over and movable with respectto at least a portion of the tubular member 210 distal to the portion ofthe tubular member over which the steering mechanism 230 is disposed.Thus, when the attachment member 260 is coupled to the endoscope, thesteering mechanism 230 and tubular member 210 can be moved with respectto the attachment member. For example, the steering mechanism 230 andtubular member 210 can be slidably movable with respect to theattachment member 260 in a longitudinal direction. In another example,the steering mechanism 230 and tubular member 210 can be rotatablymovable with respect to the attachment member 260. The attachment memberis adapted to remain substantially stationary with respect to the othermedical device when the attachment member is coupled to the endoscopeand the steering mechanism and tubular member are moved longitudinallyin a direction along the longitudinal axis and/or rotationally about thelongitudinal axis. Because the steering mechanism 230 and tubular member210 are movable with respect to the attachment member 260, the steeringmechanism and tubular member can be moved in any longitudinal orrotational direction when the attachment member is coupled to theendoscope, thus allowing for controllable placement of the distal end215 of the tubular member within the body of a patient.

The attachment member 260 is configured to guide longitudinal movementof the steering mechanism 230 and tubular member 210, for example in atleast one of a proximal or a distal direction along the longitudinalaxis L. In some embodiments, at least a portion of the attachment member260 is received within the steering mechanism 230, such as within anopening or lumen 232 of the steering mechanism. For example, a guideportion 268 of the attachment member 260, which includes the proximalend portion 263 (illustrated in FIG. 6) of the attachment member 260,can be disposed within the lumen 232 of the steering mechanism 230. Thesteering mechanism 230 is movable over the guide portion 268 of theattachment member 260 received or disposed in the steering mechanism. Insome embodiments, the guide portion 268 (or axial guide) of theattachment member 260 defines a lumen or recess adapted to receive atleast a portion of the tubular member 210. For example, as illustratedin FIG. 10, the guide portion 268 can have a semi-circularcross-section, and thus define a recess (the “U” of the semi-circle)adapted to receive a portion of the tubular member. The tubular member210 is also movable with respect to the guide portion 268 of theattachment member 260.

In some embodiments, the steerable medical device 200 includes anindicia of the longitudinal position of the distal end 215 of thetubular member 210. For example, the indicia can indicate a depth ofinsertion of the tubular member 210 into the body of the patient bycorresponding to a length of extension of the distal end 215 of thetubular member 210 beyond a distal end of the endoscope. For example, asillustrated in FIGS. 4 and 6, the device 200 includes an indicia that isa series of protrusions or teeth 248. Each protrusion (or tooth)corresponds to a measurement of the depth extension of the tubularmember 210 beyond the distal end of the endoscope and into the body ofthe patient.

In the illustrated embodiment, the indicia 284, the series of teeth 284that engage the fastener 250, and the guide 268 are the same piece ofthe device 200 having multiple functions. In other embodiments, however,the indicia is different than the teeth configured to engage thefastener and/or the guide. For example, the indicia can be included onor disposed elsewhere on the device 200. In other embodiments, forexample, the device can include an index or position indexer upon whichthe indicia is disposed, and the index or position indexer can becoupled to at least one of the steering mechanism, tubular member, orthe attachment member. Although the indicia is illustrated as a seriesof protrusions, in other embodiments, the indicia can be one or a seriesof lines, ridges, numbers, colors, or any other visual or tactileindicia corresponding to a depth of insertion of the tubular member.

In some embodiments, as illustrated in FIGS. 3 and 4, the steerablemedical device 200 includes a reinforcement (or stiffener) shaft 270.The reinforcement shaft 270 is adapted to reinforce at least a portionof the tubular member 210. For example, the reinforcement shaft 270provides reinforcement or support to the portion of the tubular member210 that is inserted into the port of the endoscope. The reinforcementshaft 270 includes a proximal end 273 and a distal end 275 and defines alumen (not shown) extending from the proximal end to the distal end ofthe reinforcement shaft.

The reinforcement shaft 270 is disposable over at least a portion of thetubular member 210. For example, the lumen of the reinforcement shaft270 is adapted to receive a portion of the tubular member 210. In someembodiments, as illustrated in FIG. 8, a portion, such as the proximalend 273, of the reinforcement shaft 270 is disposed within the lumen 232of the steering mechanism 230. In some embodiments, the proximal end 273of the reinforcement shaft 270 is coupled to the proximal end 233 of thesteering mechanism 230 and to the proximal end 213 of the tubular member210. In some embodiments, the reinforcement shaft 270, tubular member210, and steering mechanism 230 are fixedly coupled together such thatwhen one is rotated or moved longitudinally about or along thelongitudinal axis L, each of the others is correspondingly rotated ormoved longitudinally about or along the longitudinal axis L. In otherembodiments, as illustrated in FIG. 10, a reinforcement shaft 370 doesnot extend into the steering mechanism 330, but only reinforces theportion of the tubular member (not shown) extending through theattachment member 360 and entering into the port of the endoscope.

A portion of the reinforcement shaft 270 is adapted to be inserted intothe endoscope. In some embodiments, the distal end 275 of thereinforcement shaft 270 is adapted to be inserted into, or extendtelescopically into, the endoscope, such as into the port P of theendoscope S, as illustrated in dashed lines in FIG. 11.

A steerable medical device according to the invention can be used toperform or assist in a variety of medical procedures. For example, thesteerable device 200 can be used in procedures to treat conditions inthe upper urinary tract of a patient, such as kidney stones, or in thebladder of a patient, such as tumors. Referring to FIGS. 11 through 14,a medical device, such as endoscope S, is inserted into the patient'sbody. For example, in some procedures, the endoscope is inserted into abladder of the patient. The tubular (or elongated) member 210 of thesteerable medical device 200 (shown in dashed lines in FIG. 11) is atleast partially inserted into the working channel of the endoscope Sthrough port P.

The attachment member 260 of the device 200 removably couples the deviceto the endoscope S. As illustrated in FIG. 12, the fastener 250 of thesteering mechanism 230 is moved from its locked to its unlocked positionand the steering mechanism 230 is moved in a distal direction (indicatedby the arrow X in FIG. 11) with respect to the attachment member 260.Movement of the steering mechanism 230 distally when the fastener 250 isunlocked advances the tubular member 210 until its distal end 215extends beyond a distal end of the endoscope S. The steering mechanism230, and thus the tubular member 210, can be alternatively moveddistally and proximally until the operator achieves a desired extensionof the distal end 215 of the tubular member 210 beyond the distal end ofthe endoscope S.

A guidewire G is inserted into the working lumen 212 of the tubularmember 210 via the proximal opening of the steering mechanism 230. Theguidewire G is passed through the lumen 212 of the tubular member 210until a distal end of the guidewire is at or near the distal end 215 ofthe tubular member.

Referring to FIG. 13, the actuator 244 of the steering mechanism 230 ismoved in the direction of arrow Y to its second position, and thedeflectable portion 214 of the tubular member 210 is moved away from thelongitudinal axis. The actuator 244 moves a pull wire (not shown in FIG.13) to deflect the deflectable portion 214 of the tubular member 210 offof the longitudinal axis. The steering mechanism 230 is partiallyrotated in one direction with respect to the attachment member 260 (andthe longitudinal axis) towards the handle of the scope (i.e., in acounterclockwise direction), and therefore the tubular member 210 ispartially rotated in the one direction. The steering mechanism andtubular member can be rotated in clockwise and counterclockwisedirections until the deflected distal end of the tubular member faces orapproximates the target location of the body of the patient. Ifnecessary, the tubular member can be readjusted in a proximal or distaldirection to better approximate the deflected distal end of the tubularmember to the target location of the patient's body.

The ability to control deflection, rotation, and longitudinal positionof the tubular member allows the physician (or other operator) tointroduce the guidewire G, or other medical instrument, to a targetlocation within the body of the patient. For example, the physician canmanipulate the tubular member 210 until the guidewire G is positioned atthe entrance to the patient's ureter. Furthermore, the physician cancontrol the deflection, rotation, and longitudinal position of thetubular member with one hand, leaving the other hand free to manipulatethe guidewire.

With the guidewire G positioned at the target location, the attachmentmember 260 is decoupled (or removed) from the port P and the steerablemedical device 200 is removed in the direction of arrow Y, as indicatedin FIG. 13, from the body of the patient and from the endoscope S whileleaving the guidewire G substantially in position at the target locationin the body of the patient. The device 200 can be removed over theguidewire G or other medical device, leaving the guidewire G or othermedical device available in the endoscope S for further treatmentprocedures, as illustrated in FIG. 14.

Although use of the steerable medical device in a medical procedure hasbeen illustrated and described herein as occurring in one order, inother procedures the steps can occur in a different order. For example,the steering mechanism 230 and tubular member 210 can be longitudinallyand/or rotationally positioned before the distal end 215 of the tubularmember is deflected.

Additionally, although the steerable medical device has been illustratedand described herein mostly as being used in conjunction with anothermedical device (such as a rigid endoscope) and through a working channelof that other device, a steerable medical device according to theinvention can be used to controllably direct a guidewire or otherinstrument without passing through the working channel of anotherdevice.

In some embodiments, the steerable medical device 200 is a guidingcatheter adapted to be disposable after a single-use. After the operatorhas used the guiding catheter to position the guidewire, or othermedical instrument, in the body of the patient, the operator can removethe guiding catheter from the body of the patient and discard it.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly and are not limiting on the invention. The breadth and scope of theinvention should not be limited by any of the above-describedembodiments.

1. A steerable medical device, comprising: an elongated member extendingalong a longitudinal axis and including a proximal end and a distal endand defining a lumen extending from the proximal end to the distal end,the elongated member comprising a deflectable portion that includes thedistal end and that is movable off of the longitudinal axis; a steeringmechanism adapted to control movement of the deflectable portion of theelongated member, at least a portion of the steering mechanism fixedlycoupled to at least a portion of the elongated member such that rotationof the steering mechanism in one direction about the longitudinal axiscorrespondingly rotates the elongated member in that one direction aboutthe longitudinal axis; and an attachment member removably couplable toanother medical device, the elongated member and steering mechanismmovably coupled to the attachment member; wherein the steering mechanismand the elongated member are configured to be independently movable ofthe attachment member.
 2. The steerable medical device of claim 1,wherein the lumen of the elongated member is accessible through anopening defined by the steering mechanism.
 3. The steerable medicaldevice of claim 1, wherein the lumen defined by the elongated member isadapted to receive at least one of a guidewire, a stone retrievalbasket, a biopsy tool, a laser fiber, or a catheter.
 4. The steerablemedical device of claim 1, further comprising: a pull-wire coupled tothe elongated member, the pull-wire adapted to be moved by the steeringmechanism and to move the deflectable portion of the elongated memberoff of the longitudinal axis.
 5. The steerable medical device of claim4, wherein the lumen defined by the elongated member is a working lumen,the elongated member further defining a second lumen extending from theproximal end of the elongated member to the distal end of the elongatedmember, the pull-wire disposed in the second lumen of the elongatedmember.
 6. The steerable medical device of claim 1, wherein at least aportion of the deflectable portion of the elongated member is adapted toreduce deflection resistance during movement of the deflectable portion.7. The steerable medical device of claim 1, wherein at least a portionof the deflectable portion of the elongated member defines at least oneof a recess, slot, notch, or opening, the at least one recess, slot,notch or opening adapted to reduce resistance of the elongated memberduring movement of the deflectable portion of the elongated member. 8.The steerable medical device of claim 1, wherein the proximal end of theelongated member is fixedly coupled to a proximal end of the steeringmechanism.
 9. The steerable medical device of claim 1, wherein thesteering mechanism further comprises an actuator movable between a firstposition and a second position, the actuator adapted to move thedeflectable portion of the elongated member off of the longitudinal axisas the actuator is moved from its first position towards its secondposition.
 10. The steerable medical device of claim 1, wherein thesteering mechanism further comprises an actuator adapted to controlmovement of the deflectable portion of the elongated member, thesteerable medical device further comprising: a pull-wire extending fromthe steering mechanism to the distal end of the elongated member, atleast a portion of the pull-wire is coupled to the actuator.
 11. Thesteerable medical device of claim 1, wherein the steering mechanismfurther comprises an actuator adapted to control movement of thedeflectable portion of the elongated member, the actuator is disposedover a housing portion of the steering mechanism, the actuator movablewith respect to the housing portion.
 12. The steerable medical device ofclaim 1, the steering mechanism further comprising a fastener, thefastener having a locked position and an unlocked position, the steeringmechanism and the elongated member independently movable of theattachment member when the fastener is in its unlocked position.
 13. Thesteerable medical device of claim 1, wherein the attachment member isadapted to remain substantially stationary with respect to the othermedical device when the attachment member is coupled to the othermedical device and the steering mechanism and elongated member arerotated in the one direction about the longitudinal axis.
 14. Thesteerable medical device of claim 1, wherein the attachment member isadapted to couple the steerable medical device to a port of anendoscope.
 15. The steerable medical device of claim 1, furthercomprising an indicia indicating the position of the distal end of theelongated member relative to a distal end portion of the other medicaldevice.
 16. The steerable medical device of claim 1, further comprisinga reinforcement shaft including a proximal end and a distal end, thereinforcement shaft adapted to reinforce and be disposed over at least aportion of the elongated member.
 17. The steerable medical device ofclaim 16, wherein a portion of the reinforcement shaft is disposablewithin the steering mechanism, the proximal end of the reinforcementshaft fixedly coupled to the steering mechanism and to the elongatedmember, wherein the distal end of the reinforcement shaft is adapted tobe inserted into a port of the other medical device.
 18. (canceled) 19.A steerable medical device, comprising: an elongated member extendingalong a longitudinal axis and including a proximal end and a distal endand defining a lumen extending from the proximal end of the elongatedmember to the distal end of the elongated member, the elongated memberadapted to be moved to a deflected position in which a deflectableportion of the elongated member is moved off of the longitudinal axis; ahousing including a proximal end and a distal end, the housing fixedlycoupled to the elongated member such that when the housing is moved inone rotational direction about the longitudinal axis the elongatedmember correspondingly rotates in the one rotational direction about thelongitudinal axis; an actuator movably coupled to the housing; theactuator adapted to control movement of the deflectable portion of theelongated member; and an attachment member removably couplable toanother medical device, the attachment member defining a proximal endand a distal end and being disposable over at least a portion of theelongated member, at least a portion of the attachment member slidablyreceivable by the housing, the housing and the elongated member beingindependently movable of the attachment member in a longitudinaldirection.
 20. A steerable medical device, comprising: an elongatedmember extending along a longitudinal axis and including a proximal endand a distal end, the elongated member defining a lumen extending fromthe proximal end to the distal end, the elongated member comprising adeflectable portion that includes the distal end and that is movable offof the longitudinal axis, the elongated member adapted to be at leastpartially disposed in a working channel of a second medical device; anattachment member adapted to removably couple the steerable medicaldevice to the second medical device, the attachment member defining aproximal end and a distal end, the distal end of the attachment memberadapted to be removably coupled to a port of the second medical device;a reinforcement shaft adapted to reinforce at least a portion of theelongated member and disposable over at least a portion of the elongatedmember, the reinforcement shaft defining a proximal end and a distalend, the distal end of the reinforcement shaft adapted to be insertedinto the port of the ether second medical device; and a steeringmechanism adapted to control movement of the elongated member, thesteering mechanism including a housing portion fixedly coupled to atleast a portion of the elongated member, the steering mechanismincluding an actuator adapted to control movement of the deflectableportion off of the longitudinal axis; wherein the steering mechanism andthe elongated member are configured to be independently movable of theattachment member.
 21. A steerable medical device of claim 20, whereinrotation of the steering mechanism in one direction about thelongitudinal axis correspondingly rotates the elongated member in thatone direction about the longitudinal axis.